Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
Open Solicitation Posted
- Solicitation number
- 75A50126R00001_RFP_NPIVS_27
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Place of performance
- Washington, District of Columbia 20024, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
HHS's Office of the Assistant Secretary for Preparedness and Response, through BARDA, seeks multiple IDIQ contractors for the Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program, with proposals due November 20, 2026 at 5:00 p.m. EST. No set-aside is used, but eligibility requires offerors to hold a U.S. influenza vaccine license or have submitted a Biologics License Application for a seasonal or pandemic influenza vaccine.
The notice lists Washington, DC 20024 as place of performance. The RFP prefers U.S. manufacturing facilities and requires that product manufactured outside the continental U.S. ship to U.S. storage within 60 days of lot release. Scope covers candidate vaccine virus development, cGMP seed lots, bulk antigen and adjuvant manufacturing, fill-finish, storage and stability testing, analytical testing, nonclinical and clinical studies, shipping, and disposal. Activities 1010 through 1017 and their option-period equivalents are priced at the task order level.
The contract is an IDIQ with a 60-month base period, one 60-month option period, a 120-month ordering period, a $50,000 minimum guarantee, and no stated maximum. Contract types are firm-fixed-price, firm-fixed-unit-price, and cost-reimbursement. Pricing is fixed at award with no annual escalation on firm-fixed-unit-price CLINs. Award is anticipated in August 2027.
Required technical submissions include validated manufacturing sites and lines with facility blueprints, a Bill of Materials, a Manufacturing Plan, business continuity and supply continuity plans, a surge readiness assessment, and an ASPR security attestation. Clinical work requires IRB approval, single-IRB compliance for multi-site studies, and ClinicalTrials.gov registration. The government receives the lowest price offered to high-income nations under the fair product pricing provisions. Offerors must submit proposals for all available manufacturing platforms.
Evaluation consists of Factor A (technical methodology, organizational experience, facilities, and key personnel), Factor B (past performance), and Factor C (cost/price). Technical capability is weighted significantly more heavily than the other factors, and cost realism applies to cost-reimbursement activities. Submissions go through the BDR Portal, and SAM registration is required before award.
Amendment 0001 extended proposals to November 20, 2026 and supplemental questions to October 1, 2026 at 12:00 p.m. EST. Amendment 0002, posted October 26, 2026, adds Attachment 21 with BARDA's responses to contractor questions 1 through 10. NAICS is 541714 and PSC is AN12.
Notice text
2 versions
Update #2 · Latest ·
BARDA seeks Contractor(s) to support the continuation of the Vaccine Medical Counermeasures (MCM's) for Pandemic Influenza Preparedness and Response Program. Contractors will furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities (U.S. facilities preferred) not otherwise provided by the USG as needed to provide MCMs, such as vaccines, antigens, and adjuvants, for pandemic preparedness and response or as required in response to a public health emergency; produce antigen and vaccines against influenza virus or other viruses with pandemic potential as required by BARDA; produce antigens, adjuvants, and/or vaccines to support USG efforts to further improve influenza vaccines (for which feasibility data is available); and support rapid regulatory decisions and manufacturing readiness by generating and submitting to FDA all relevant data (e.g., analytical, nonclinical, clinical, and/or chemistry, manufacturing, and controls (CMC)), including data generated during interpandemic periods.
Mandatory Qualification Requirements:
To be eligible for award, the Offeror must produce vaccines against influenza and influenza strains with pandemic potential; must demonstrate a successful experience in the manufacturing of influenza vaccine by:
1. Holding a U.S. influenza vaccine license; or
2. Have developed an influenza vaccine as evidenced by:
a. Submission of a Biologics License Application (BLA) for seasonal or pandemic influenza vaccine
Please see full solicitation details and proposal submission instructions detailed in attachments 01-21 of this notice.
Update #1 ·
BARDA seeks Contractor(s) to support the continuation of the Vaccine Medical Counermeasures (MCM's) for Pandemic Influenza Preparedness and Response Program. Contractors will furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities (U.S. facilities preferred) not otherwise provided by the USG as needed to provide MCMs, such as vaccines, antigens, and adjuvants, for pandemic preparedness and response or as required in response to a public health emergency; produce antigen and vaccines against influenza virus or other viruses with pandemic potential as required by BARDA; produce antigens, adjuvants, and/or vaccines to support USG efforts to further improve influenza vaccines (for which feasibility data is available); and support rapid regulatory decisions and manufacturing readiness by generating and submitting to FDA all relevant data (e.g., analytical, nonclinical, clinical, and/or chemistry, manufacturing, and controls (CMC)), including data generated during interpandemic periods.
Mandatory Qualification Requirements:
To be eligible for award, the Offeror must produce vaccines against influenza and influenza strains with pandemic potential; must demonstrate a successful experience in the manufacturing of influenza vaccine by:
1. Holding a U.S. influenza vaccine license; or
2. Have developed an influenza vaccine as evidenced by:
a. Submission of a Biologics License Application (BLA) for seasonal or pandemic influenza vaccine
Please see full solicitation details and proposal submission instructions detailed in attachments 01-19 of this notice.
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Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Solicitation | |
| Presolicitation Notice - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response | Pre-Solicitation | |
| BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response | Pre-Solicitation |
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